Pilot Scale Lyophilizer
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Pilot Scale Lyophilizer

1.Laboratory Freeze Dryer:
(a)10 series
Lab Scales Desktop(Freeze-dried material 1.5-2KG)
(b)12 series
Lab Scales Vertical(Freeze-dried material 2KG)
(c)18 series
Scientific Research Scales(Freeze-dried material 3KG)
2.Pilot Freeze Dryer:
0.2m²/0.3m²/0.5m²/1m²/2m²/---Pilot Scales(Freeze-dried material 3KG-20KG)
3.Industrial Freeze Dryer:
5㎡/10㎡/20㎡/30㎡/50㎡/100㎡/200㎡/300㎡(Freeze-dried Weight 5T~60T)
4.Customization: set up the specifications you need
(a)Freeze-dried Area
(b)Freeze-dried Weight
(c)Freeze-dried Material
(d)Interlayer Quantity/Size
(e)Cold Trap Temperature
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Description

Technical Parameters

The pilot scale lyophilizer is used in the pharmaceutical industry to produce dry pharmaceutical powder,which can be stably stored at room temperature for a long time and is easy to transport and use. At present,the main production areas for pilot scale freeze-drying machines include China,Europe,etc.,and a group of excellent manufacturers and brands have also emerged in the market.With its high flexibility,excellent material recovery rate and product quality,intelligent operating system,and multiple safety protection measures,it plays an increasingly important role in scientific research and industrial production.With the continuous innovation of technology and the continuous expansion of the market,the pilot freeze-drying machine is expected to achieve more widespread application and deeper development in the future.

 

Freeze dryer | Shaanxi Achieve chem-tech

 

Specifications Table

 

Electric Heating

 

Freeze Dryer Heating Method | Shaanxi Achieve chem-tech

Silicone Oil Heating

 

Freeze Dryer Heating Method | Shaanxi Achieve chem-tech

 

Freeze Dryer Heating Method | Shaanxi Achieve chem-tech

 

Freeze Dryer Heating Method | Shaanxi Achieve chem-tech

 

Freeze Dryer Heating Method | Shaanxi Achieve chem-tech

 

Influence factor

 

The exhaust temperature of the freeze dryer is controlled by the operator of the freeze dryer.If it cannot be controlled,it indicates that our freeze dryer has malfunctioned.Before dealing with a freeze dryer malfunction,we must understand what is affecting the exhaust temperature of the freeze dryer.

 

From the perspective of energy utilization

 

It is hoped that the higher the exhaust temperature of the machine,the better,and preferably the same as the intake temperature,at which point the "waste cooling" is zero.But in reality,this cannot be achieved,and it is not uncommon for the temperature difference between the inlet and outlet of a freeze-drying machine to exceed 15 ℃.

  • Energy is inevitably lost during the process of transmission and exchange;
  • The heat transfer coefficient of homogeneous gases with low temperature and small temperature difference in wall convection heat transfer (especially in downstream heat transfer) is not large;
  • In the process of heat exchange,the cooling of saturated hot air flow is inevitably accompanied by a phase change.A portion of the absorbed cold energy must be used to pay for the latent heat of the phase change,thereby limiting the temperature reduction of the hot air flow.This in turn limits the increase in temperature of the cold air flow.

 

In terms of exhaust temperature

 

The reason for the high exhaust temperature of the freeze dryer

 

 

During the overhaul of the air compressor head,it is sometimes abnormal for the exhaust temperature of the freeze dryer to be too high,which may be:

  • The compressed air temperature is too high or the flow rate is too high;
  • Changes in the working conditions of the refrigeration system cause an increase in the evaporation temperature of the refrigerant,resulting in insufficient cooling of the compressed air in the evaporator;
  • The heat dissipation on the outer wall of the precooler pipeline is too large.

 

The reasons for the low exhaust temperature of the freeze-drying machine include

 

 

  • Insufficient heat transfer area of the precooler and excess cooling capacity of the evaporator;
  • low inlet temperature or low flow rate of compressed air;
  • The working conditions of the refrigeration system have changed,causing the refrigerant evaporation pressure to be lower than the normal value.

 

Only by understanding the factors that affect the exhaust temperature of the pilot scale lyophilizer can we better handle faults in a timely manner and reduce losses. Freeze dryer is one of the equipment commonly used in factories in summer. In the precooler,cold and hot compressed air exchange heat and mass,and the total heat exchanged is equal.However,the saturated hot air flow undergoes a phase transition during the cooling process.The occurrence of condensed water requires a portion of the cooling capacity to be consumed.And all the heat absorbed by the cold air flow during the heat exchange process is used for heating,so the temperature change amplitude of the cold and hot air flows is different.The rule is that the cooling amplitude of the hot air flow is smaller than the heating amplitude of the cold air flow.For example,under certain operating conditions,hot air can decrease from 40 ℃ to 28 ℃,with a decrease of 12 ℃,while cold air can increase from 5 ℃ to 24 ℃,with a increase of up to 19 ℃.

 

Performance characteristics

Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech
 

High-efficiency refrigeration and water capture capacity: By adopting cascade refrigeration technology, it features a large cooling capacity and strong water capture ability, which can rapidly lower the material temperature and effectively collect the sublimated water, significantly reducing the freeze-drying time. For instance, the temperature of the cold trap can be as low as -85℃, and the water capture capacity can reach over 6L/24h, ensuring the drying efficiency.

 

High-precision temperature control and uniformity: The shelf temperature is precisely controlled through silicone oil circulation, with a temperature error of ≤1℃, ensuring temperature consistency at all points. This design avoids local overheating or overcooling, and is particularly suitable for temperature-sensitive biological products and medicines, ensuring stable drying quality.

 

Full automation and intelligent monitoring: The equipment is equipped with a programmable control system, supporting full-process automated operation from pre-freezing to drying. The process curve and data are displayed in real time through the touch screen. Users can intuitively monitor parameters such as temperature and vacuum degree, and it supports data storage and export, which is convenient for process optimization and traceability.

 

Structural and material advantages: The freeze-drying room is made of 304 stainless steel, which is corrosion-resistant and easy to clean. The drying room is equipped with a high-transparency plexiglass door, which facilitates the observation of the material state. In addition, the equipment is equipped with independent safety designs such as overcurrent and overload protection to ensure operational reliability.

 

Flexible configuration and scalability: It offers optional functions such as eutectic point testing devices and automatic stoppering devices to meet different process requirements. Some models support a wall-penetrating isolation design, which is suitable for the layout of clean workshops and compatible with various containers such as vials and ampoules, enhancing production flexibility.

 

Energy conservation and low noise: Equipped with imported ultra-quiet compressors and an optimized refrigeration system, it ensures performance while reducing energy consumption and noise, making it suitable for long-term operation in laboratories and pilot plants.

Material handling system

 

The material handling system of the pilot scale lyophilizer is an important part of it, which is mainly responsible for the loading, unloading, transmission and treatment of the material during the freeze-drying process.

Main function

 

Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech

Material loading and unloading

  • Material handling systems are usually equipped with material pallets or trays for loading materials to be freeze-dried.
  • Pallets or trays should be designed to facilitate loading and unloading of materials while ensuring stability and uniformity during the freeze-drying process.
  • Some material handling systems may also be equipped with automatic entry and exit devices to further increase production efficiency.
Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech

Material transfer

  • During the freeze-drying process, the material needs to be transferred at different stages, such as from the loading area to the freeze-drying chamber, or from the freeze-drying chamber to the unloading area.
  • The material handling system should be able to ensure the safety and stability of the material during transmission and avoid material damage or contamination.
Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech

Freeze-drying process

  • During the freeze-drying process, the material handling system may need to stir, flip, or vibrate the material to ensure that the material is evenly heated and dried.
  • These operations help improve lyophilization efficiency and quality while reducing temperature and humidity gradients within the material.
Technical characteristics
 
 

Automation and intelligence

The material handling system of modern pilot scale freeze-drying machine is usually equipped with automation and intelligent technology, such as automatic feed in and out device, automatic mixing device, etc.

These technologies reduce manual intervention and increase production efficiency while ensuring stability and consistency in the lyophilization process.

 
 
 

Modular design

The material handling system usually adopts a modular design, which is easy for users to select and configure according to actual needs.

The modular design also allows users to expand and upgrade the material handling system according to production requirements.

 
 
 

Easy to clean and maintain

Material handling systems should be designed with the need for easy cleaning and maintenance in mind.

It is usually designed with removable parts and easy access for users to carry out daily cleaning and maintenance work.

 

Application advantage

Improve production efficiency

Automated and intelligent material handling systems reduce manual intervention and increase production efficiency.

By optimizing the material transfer and handling process, the freeze-drying cycle can be shortened and the equipment utilization rate can be improved.

Ensure product quality

The material handling system ensures stability and uniformity during the freeze-drying process.

By optimizing operations such as stirring, flipping or vibration, the temperature and humidity gradients within the material can be reduced, thereby improving the freeze-drying quality.

Reduce operating costs

Automated and intelligent material handling systems reduce labor costs and energy consumption.

By optimizing the freeze-drying process and improving equipment utilization, operating costs can be reduced and overall economic benefits improved.

 

How to store after drying

 

 
 
Sealed storage
Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech
01.

Container selection

Use containers with good sealing performance, such as plastic bags, glass bottles or aluminum foil bags, etc., to prevent pollution and corrosion of substances by air, moisture and dust.

Make sure the inside of the container is dry, clean and free of residual water or impurities.

02.

Sealing operation

Immediately after loading the material into the container, seal the mouth of the container to ensure a tight seal.

For substances that need to be stored for a long time, vacuum packaging or nitrogen-filled packaging can be considered to further reduce the oxygen content and extend the storage period.

Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech
 
 
Low temperature storage
Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech
01.

Temperature control

Store the dried material in a low temperature environment, such as a refrigerator or freezer. It is generally recommended to store below 4 ° C, and for particularly sensitive substances, it can be stored in an environment below minus 20 ° C.

Avoid exposure to high temperatures, so as not to cause quality degradation or failure.

02.

Temperature monitoring

Periodically check the temperature of the storage environment to ensure that the temperature is within the set range.

If the temperature is abnormal, take immediate measures to adjust it.

Pilot Scale Lyophilizer | Shaanxi Achieve chem-tech
1. Store away from light
  • Storage location:

Store the material in a dark place, such as drawers, closed cabinets or blackout bags, to prevent light from affecting and damaging the material.

  • Light protection measures:

Use light-resistant containers or packaging materials, such as black or dark plastic bags, aluminum foil bags, etc.

Avoid direct exposure to sunlight or strong light.

2. Dry environment
  • Humidity control:

Ensure that the humidity of the storage environment is low to protect the material from moisture. A desiccant or dehumidifier can be used to reduce humidity.

  • Moisture-proof measures:

Place desiccant, such as silica gel, lime, etc. in the container to absorb moisture that may enter the container.

Avoid contact with water or wet ground.

3. Avoid squeezing or friction
  • Placement method:

Place the material flat in the container to avoid stacking or being squeezed.

Use appropriate filler or support to ensure that the substance remains stable in the container.

  • Transportation precautions:

During transportation, avoid violent vibration or collision, so as not to cause damage to the material.

Use special transportation packaging materials, such as foam boxes, shock pads, etc., to protect the material from external shocks.

4. Regular inspection and replacement
  • Validity period management:

Pay attention to the expiration date of the substance and use it within the expiration date. Substances that exceed their expiration date may experience problems such as deterioration or failure.

  • Regular inspection:

Periodically check the temperature, humidity and other conditions of the storage environment to ensure that they are within the set range.

Check the sealing performance of the container is good, if there is damage or leakage should be replaced in time.

 

A pilot scale lyophilizer is a specialized piece of equipment utilized in the pharmaceutical, biotechnology, and food processing industries for the purpose of freeze-drying or lyophilization on a smaller, experimental scale. It serves as a bridge between laboratory-scale research and full-scale production, enabling scientists and engineers to test and optimize freeze-drying processes before implementing them on a larger commercial level.

Operating on the principle of sublimation, a lyophilizer gently removes water from a product by freezing it and then applying a vacuum to cause the ice to directly transition from solid to vapor without passing through the liquid phase. This process preserves the product's structure, activity, and stability, making it ideal for sensitive materials such as vaccines, biopharmaceuticals, enzymes, and certain foods.

The use offers several advantages. It allows for the simulation of large-scale conditions, enabling researchers to identify potential process bottlenecks and make adjustments accordingly. It also facilitates the development of new formulations and packaging configurations, ensuring that products meet quality standards before large-scale manufacturing begins. Furthermore, pilot-scale testing can help estimate production costs and timelines, aiding in decision-making related to scale-up and commercialization.

In summary, a pilot scale lyophilizer is a crucial tool for the development and optimization of freeze-drying processes. Its ability to bridge the gap between research and production makes it indispensable in the quest for efficient, high-quality manufacturing of sensitive products across various industries. By providing a controlled environment for experimental freeze-drying, it enables scientists and engineers to innovate, refine, and ultimately bring life-saving and life-enhancing products to market.

 

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